WOM Tube Set for lrrlgatlon, single-use- Intended to transport irrigation fluid to the patient in endoscopic surgeries. Distr. by Endoscopy Smith & Nephew Inc. REF Numbers: T0449-01
This recall is currently active, issued July 1, 2024. It was issued by Wom World Of Medicine Ag Alte Poststr. 11 Ludwigsstadt Germany.
- Recall Initiated
- May 24, 2024
- Posted
- July 1, 2024
- Recall Number
- Z-2243-2024
- Quantity
- 1700 units
- Official Source
- View on FDA website ↗
Reason for Recall
Incorrect transponder data was written on the RFID tags triggers the error message E03, Tube Set lnvalid, may result in a delay of surgery
Distribution
US Nationwide distribution.
Lot / Code Info
UDI: 04056702003678 Lot Numbers: 4030902, 4030903
Root Cause
Process control
Action Taken
Smith & Nephew Issued Urgent Field Safety Notice (FSN) - MEDICAL DEVICE RECALL WOM reference no.: 2024-0001 via email on 5/24/23. Letter states reason fo recall, health risk and action to take; lnform individuals within your organization who need to be aware of this recall. - Check all stock areas and/or operating room storage to determine if any tube sets with lol numbers from Annex 'l are at your facility, - Dispose of all affected tube sets properly. Confirm this on the customer response form. Return the form to fieldactions@smith-nephew.com. Please send any questions to fieldactions@smith-neDhew.com